CENTERPIECE
Pioneering the Strategic Combination of ETO Sterilization and Contract Manufacturing

FOR MEDICAL DEVICE COMPANIES, a well-designed and reliable supply chain is the foundation for operational success. This means that all portions hereof – from sourcing to manufacturing to product sterilization – work together reciprocally so that all components of a finished product meet necessary specifications and reach their respective destinations.

Supply chain disruptions can have an endless array of causes, however the prevailing threat in the medical device industry stems from ethylene oxide (ETO) sterilization processing. Sterilization is most commonly an outsourced service; thus, supply chains are inherently fragmented and geographically disconnected.

Moreover, there is a shortage of available ETO sterilization capacity in North America and as a result, supply chains are becoming increasingly inefficient and costly. Medical device companies are often seeking out ETO sterilization capacity wherever they can find it, even if located thousands of miles away from production facilities.

As per the Food & Drug Administration (FDA) website, “literature shows that about fifty percent of all sterile medical devices in the U.S. are sterilized with ethylene oxide”.

Supply chain disruptions of this magnitude and scale in particular, can have a devastating impact on a business’ operational performance and profitability.

This Marks The Principal Industry Differentiator For Centerpiece

Centerpiece is a medical device contract manufacturing and ethylene-oxide sterilization company headquartered in San Diego, California. Primary operations are in, and around, Tijuana, Mexico–North America’s leading medical device production center for US markets.

Its business model is to serve as the “operational centerpiece” for complex medical device supply chains, by directly linking manufacturing with in-house sterilization. Centerpiece is ISO 13485 certified, ISO 11135 compliant, and FDA registered.

“We assessed the complete ecosystem of our industry and built an organization around it. There’s only one medical device company that has contract manufacturing and in-house ETO sterilization capabilities of this scale, and that’s Centerpiece,” says Matt Jordan, CEO of Centerpiece.

One-Stop Manufacturing and Sterilization

Located 10 minutes south of the U.S. border, and 45 minutes from San Diego International Airport, Centerpiece’s ETO sterilization facility resides in Tijuana, Mexico – one of the world’s largest medical device manufacturing hubs. Importation of goods in and out of Mexico is efficient, and in 2024 a new Port of Entry will become available to further streamline the flow of goods.

Centerpiece’s contract manufacturing facility is located thirty minutes west of its ETO sterilization operation and offers primary services such as clean room assembly and sterile-barrier packaging. The team manages all processes within a medical device’s supply chain, including component sourcing & procurement, product manufacturing, and logistics coordination with its sterilization facility. For businesses that outsource manufacturing to Centerpiece, the company offers priority ETO sterilization scheduling and guarantees ETO sterilization capacity.

For companies looking to commercialize their products in the US market, Centerpiece offers specialized engineering services such as product development and design-for-manufacturability,

along with manufacturing incubation & launch capabilities – each complimented with low volume and economical ETO sterilization processing and testing.

When it comes to sterilization services, Centerpiece highlights four areas. First, its production processing leverages the highest quality sterilization equipment and can process in high-volume or low-volume batches. The facility’s chamber configuration consists of four 10 pallet chambers, four 20 pallet chambers, one 2 pallet chamber, and one 1 pallet chamber. Second, Centerpiece can develop new ETO sterilization cycles, as well as optimize existing sterilization recipes. Large companies partnering with Centerpiece have successfully been able to consolidate legacy cycles across different business units, creating strategic and holistic ETO sterilization solutions for the enterprise. Next, and in concert with its product development efforts, Centerpiece offers material compatibility engineering services for both product and packaging. As a medical device company solidifies its product design characteristics, the long-term sterilization strategy must be considered. Last, Centerpiece offers industry-best accelerated product aeration processing and sterile product warehousing. The company has installed a world class emission control system that allows products to degas safely and efficiently.

Being Responsive to Environmental Concerns

Ethylene Oxide gas is the most common sterilization method used worldwide and more than twenty-five billion devices are processed annually. However recently, there have been environmental concerns related to fugitive emissions. In response, Centerpiece has installed the latest emissions control technology from LESNI, a Danish company dedicated to developing and producing air purification systems for cleaning industrial exhaust. The technology includes a Catalytic Abatement Plant (CAP) to purify exhaust air from the processing, aeration, and sterile-product warehousing processes. The LESNI abatement plant supersedes US emissions limit legislations requiring better than 99% purification or less than one detectable part-per-million in emissions. Centerpiece’s growing partnership with LESNI helps the company achieve a critical component of its mission and vision – to operate as the cleanest and safest ETO sterilization facility in the world. Comparing its sterilization emissions control system to that of legacy sterilization facilities, Jordan colorfully provides the following analogy – “if legacy sterilization facilities are a 1970’s Chevy truck, our facility is a 2022 Tesla”.

Forming and Nurturing Partnerships

Centerpiece’s low volume sterilization processing capability, using one and two pallet sterilization chambers, has been exceptionally welcomed by the medical device industry. “The reception and level of interest has been overwhelmingly positive”, say Jordan. Budding companies forecasting significant growth have actively engaged with Centerpiece, looking for a partner to sterilize products and help them commercialize in the industry. This initial engagement often leads to an expanded partnership, whereby Centerpiece also assembles and packages the medical devices.

Additionally, Centerpiece offers its customers the ability to rapidly scale and ramp up output, by leveraging both the expansive labor pool in Mexico and its larger ETO sterilization chambers.

Having established itself as a “go-to” partner for medical device contract manufacturing and ETO sterilization, Centerpiece will soon be expanding its business model into the US and Europe – at the industry’s request. “Our business model links together the product’s value chain and we are able to provide our customers with a finished device. Other contract manufacturers advertise an end-to-end solution, however they conveniently omit sterilization. A product should not be considered ‘finished’ unless it’s sterile and ready for use in surgery or procedure”, concludes Jordan.